Compliance to Ophthalmic Follow-up Examinations and Surgical Outcome for Proliferative Diabetic Retinopathy

July 31, 2012 updated by: Makoto Inoue, Kyorin University

Compliance to Ophthalmic Follow-up Examinations Affect Outcome of Vitrectomy for Proliferative Diabetic Retinopathy

The relationship between the surgical outcome of vitreous surgery for proliferative diabetic retinopathy and the compliance to ophthalmic follow-up examinations was evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The medical records of 94 patients that had undergone vitreous surgery for proliferative diabetic retinopathy (PDR) and were followed for at least 6 months were reviewed. The subjects were divided into three groups; the never-treated group consisting of patients who had no previous ophthalmic examination until the first visit when vitreous surgery was prescribed; the non-compliant group consisting of patients with a history of missing ophthalmic examination over a one year period, and the compliant group consisting of patients who had ophthalmic examinations at least once a year. The evaluations included age, gender, plasma level of glycosylated hemoglobin (HbA1c) at the preoperative examination, presence of preoperative panretinal photocoagulation, preoperative best-corrected visual acuity (BCVA), postoperative BCVA at the final examination, status of the PDR, the numbers of vitreous surgeries, and presence of pre- and postoperative neovascular glaucoma.

Study Type

Observational

Enrollment (Actual)

94

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Mitaka, Tokyo, Japan, 181-8611
        • Kyorin Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The patients that underwent their first vitreous surgery for proliferaftive diabetic retinopathy

Description

Inclusion Criteria:

  • One hundred and twenty-eight eyes of 94 patients that had undergone vitreous surgery for proliferative diabetic retinopathy.
  • Type 2 diabetes.

Exclusion Criteria:

  • The patients were not followed more than 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Never-treated group
The patients who had no previous ophthalmic examination until the first visit when vitreous surgery was prescribed
Procedure: Vitrectomy
Vitrectomy. Diabetic retinopathy
Other Names:
  • Compliance of follow-up
The non-compliant group
The patients with a history of missing ophthalmic examination over a one year period
Procedure: Vitrectomy
Vitrectomy. Diabetic retinopathy
Other Names:
  • Compliance of follow-up
The compliant group
The patients who had ophthalmic examinations at least once a year
Procedure: Vitrectomy
Vitrectomy. Diabetic retinopathy
Other Names:
  • Compliance of follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative status
Time Frame: Preoperative period
Plasma level of glycosylated hemoglobin (HbA1c)
Preoperative period
Preoperative status
Time Frame: Preoperative period
Best-corrected visual acuity (BCVA),
Preoperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative status
Time Frame: up to 1 year
Postoperative best-corrected visual acuity (BCVA) at 6 months and the final examination
up to 1 year
Postoperative status
Time Frame: up to 1 year
Status of the proliferative diabetic retinopathy
up to 1 year
Postoperative status
Time Frame: up to 1 year
Presence of neovascular glaucoma.
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyorin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

March 1, 2011

First Submitted That Met QC Criteria

March 1, 2011

First Posted (Estimate)

March 2, 2011

Study Record Updates

Last Update Posted (Estimate)

August 2, 2012

Last Update Submitted That Met QC Criteria

July 31, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kyorineye003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Proliferative Diabetic Retinopathy

Clinical Trials on Vitrectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe